Autoimmune-Summaries: Daily Autoimmune Updates at a Glance
- decodeMR Team
- 2 days ago
- 2 min read
Updated: 22 hours ago
27/08/2026
AbbVie submitted a regulatory application to the EMA for SC induction dosing of risankizumab in adults with moderately to severely active CD (Ref)
AbbVie announced that it had submitted an application to the European Medicines Agency (EMA) seeking approval of SKYRIZI® (Risankizumab; IL-23 inhibitor) for subcutaneous (SC) induction for the treatment of adult patients with moderately to severely active Crohn's disease (CD).
The application to the EMA was supported by the recently shared positive data from the Phase 3, AFFIRM/ NCT06063967 study1.
The Phase 3 trial evaluated the efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active CD, in those with and without prior advanced therapy failure.
TEZSPIRE® demonstrated positive phase 3 results in eosinophilic esophagitis across both co-primary and all key secondary endpoints (Ref; Ref)
Amgen and AstraZeneca announced positive topline results from the Phase 3, CROSSING trial of TEZSPIRE® (tezepelumab-ekko) in patients living with eosinophilic esophagitis (EoE).
TEZSPIRE demonstrated statistically significant and clinically meaningful improvements across co-primary and key secondary endpoints at week 24 which were sustained through week 52.
The co-primary endpoints were histologic remission and the frequency and severity of dysphagia (difficulty swallowing).
The safety profile of TEZSPIRE was generally consistent with its approved indications.
Argenx completed the acquisition of Forte Biosciences (Ref)
Argenx announced the successful completion of the acquisition of Forte Biosciences, and the deal expended its immunology portfolio with FB102 (anti-CD122) a candidate with clinical proof-of-concept in vitiligo and celiac disease and the potential to address multiple autoimmune diseases.
Argenx completed the acquisition at $77.00 per share in cash.
FB102 demonstrated clinical proof-of-concept in vitiligo and celiac disease.
A Phase 2 study of FB102 in celiac disease is ongoing, with data expected in 2H 2026, while a Phase 1b study in alopecia areata is also ongoing with data expected in 2H 2026.
Priovant announced the US FDA approval of brepocitinib for adults with dermatomyositis (Ref)
Priovant Therapeutics announced that the US FDA had approved LISRAYA™ (brepocitinib; TYK2/JAK1 inhibitor) 30 mg for the treatment of adults with dermatomyositis (DM).
LISRAYA’s approval followed the landmark Phase 3 VALOR trial.
LISRAYA, a once-daily pill was designed to directly target key immune pathways implicated in DM pathogenesis.
LISRAYA demonstrated robust efficacy on multiple measures of DM disease activity, accompanied by substantial steroid-sparing benefits, in the largest dermatomyositis clinical trial ever conducted.
